A randomised controlled trial of SHORT duration antibiotic thERapy for critically ill patients with sepsis. The trial will be conducted in 2244 adult, critically ill, patients with suspected or confirmed sepsis. The trial will compare 5-day fixed course of initial antibiotic treatment for sepsis with standard care.
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Co-Primary Outcome:
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28-day all-cause mortality
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Total antibiotic treatment days at 28 days
INCLUSION CRITERIA
Patients must fulfil all of the following inclusion criteria prior to randomisation:
1. Adult patients, age ≥ 18, treated within a critical care setting (ICU or HDU) for suspected or confirmed sepsis due to either community- or hospital-acquired infections
2. Evidence of new or worsening acute organ dysfunction resulting from suspected or confirmed infection (e.g. the treatment or monitoring of an organ dysfunction)-so presence of an arterial line, placed in response to new severe sepsis, even in the absence of organ support still allows inclusion
3. Antibiotics initiated for suspected or confirmed sepsis and able to be randomised within 4 days of the initiation of this course of antibiotics (see 3.3.1 Defining index course of antibiotics for sepsis).
EXCLUSION CRITERIA
Patients must not meet any of the following exclusion criteria to be randomised:
1. Comorbidity with immunosuppression (e.g. Chemotherapy, maintenance steroids equivalent to >10mg/day of prednisolone, post-transplantation)
2. Blood neutrophil count less than 0.5 x 109 /L secondary to a pre-existing comorbidity
3. Infection source where usual practice involves more than 14 days of antibiotics (e.g. undrainable abscess, endocarditis, Staphylococcus aureus bacteraemia, osteomyelitis)
4. Receiving end-of-life care
5. Life-sustaining treatment expected to be withdrawn within the next 24 hours 6. The clinician responsible for the patient’s care is unable to adhere to the intervention
Study Information
This study compares a short course (5 days) of antibiotics versus standard care.
The research question involves comparison of mandated short duration (5 days) of effective antibiotic vs standard care.
It is crucial to decide which antibiotic(s) are your primary effective antibiotic intervention and then STOP this/these after a 5 day course. IF the clinically responsible consultant/microbiologist wants to continue beyond 5 dsys then there needs to be a documented justified 'represcription'.
There are many permutations and combinations of possible scenarios in relation to SHORTER, for example commencement on ward; escalation, de-escalation and so on. When making decisions about this, the Case Report Form will help; as will trying to address the primary research question.
Ensuring HRA guidance and Mental Capacity Act adherence in relation to consent and ongoing consent, especially in the context of loss of patient capacity, is important (as with all research).
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HINTS & TIPS
-The 5 day SHORT INTERVENTION ARM includes ALL TREATMENT ANTIBIOTICS UP TO 5 DAYS-so if have 4 days of Tazocin and escalate to Meropenem on day 5, then Mero can only be given for 1 day. After this justified extended course needs to be represcribed -YOU ARE NOT ALLOWED TO JUST EXTEND THE CURRENT COURSE. IT MUST BE AN ACTIVE DECISION.
-ACERT team have decided not to enrol any patients who are listed for discharge-this is because this intrinsically implies they will not meet the inclusion criteria.
-SHORTER trial team have asked that we try to enrol sicker patients, although this can be more challenging, and exclusions are more likely to be present.
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-In relation to immunosuppression
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Chronic use of steroids/immunosuppression – exclude
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Acutely starting immunosuppression– exclude
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Acute use of steroids that we wouldn’t normally consider to be immunosuppressive – COPD and sepsis - include.
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INTERVENTION PATIENTS (Allocated 'SHORT DURATION')
-Write in ALL TREATMENT ANTIBIOTICS within general and pharmacy notes (note latter have character limit): please write the FINAL DATE/TIME
-Write a short research note stating the allocation and highlighting that the antibiotic prescription must stop at end of day 5. Specifically state that must NEVER EXTEND the prescription. If the clinical team or micro team want to continue antibiotcs beyond 5 days...they must write a new 'extended prescription' course, justifying WHY extended antibiotic benefit offsets the known risks of resistance, organ toxicity and gut injury.
-Copy this note to the handover on tasks.
Ensure that SHORTER is visible on the Research tab within the storyboard AND associate ALL treatment antibiotics with SHORTER trial.
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STANDARD CARE-No additional documentation. Do NOT associate antibiotics. Do NOT write in the antibiotic prescriptions. ICU team can adopt 'usual care' decision making around duration of antibiotics.
